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Toripalimab Combined With Definitive CCRT for LACC Patients

ConditionsCervical CancerChemoradiotherapyImmunotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRuijin Hospital

About this trial

Cervical cancer constitutes a significant health burden for women globally. While most patients with early-stage disease can be cured with radical surgery or chemoradiotherapy, patients with high-risk locally advanced disease or with recurrent/metastatic disease have a poor prognosis with standard treatments. Immunotherapies are a rational treatment for this HPV-driven cancer that commonly expresses programmed cell death ligand-1. Toripalimab, a humanized immunoglobulin G4 monoclonal antibody against PD-1, showed promising anti-tumor efficacy in multiple solid tumors. This randomised study is evaluating toripalimab combined with CCRT versus CCRT alone for treatment-naïve LACC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

more than 18 years old females

had newly diagnosed and previously untreated locally advanced squamous cell carcinoma of the uterine cervix

FIGO 2018 stage IB3 to IVA with no evidence of distant metastasis

ECOG PS 0-1 without major organ failure

Disqualifiers

previously suffered from immunodeficiency disorders

had any condition that researchers believed to be associated with increased risk of treatment

Previously received or currently receiving other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1

Trial design

Design model

Parallel

Treatments tested in this trial

  • Toripalimab

    Drug

    Toripalimab combined with CCRT

  • CCRT

    Radiation

    CCRT includes cisplatin (40 mg/m2, once a week for 5 weeks), radiotherapy (45-50.4Gy/25-28Fx, 5 fractions a week, followed by brachytherapy 24-30Gy/3-5Fx)

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Toripalimab+CCRTExperimental treatment 2 interventions
Group B: CCRTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

2-year progression-free survival

the date of the treatment to the date of disease progression or death from any cause in the absence of progression

Time frame
2 year

Secondary outcomes

1

2-year local control

absence of disease in the cervix (uterus), upper vagina or parametria on clinical examination, imaging, and biopsy

Time frame
2 year
2

2-year local regional control

absence of disease in the cervix (uterus), upper vagina or parametria and regional lymph nodes on clinical examination, imaging, and biopsy

Time frame
2 year
3

2-year overall survival

the time from the start of treatment until the date of death from any cause.

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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